other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

The study report states that the test was performed in accordance with EEC 84/449 Method C10. However, this test method does not refer to a hydrolysis study and hence is considered to be a typographical error in the report.

GLP compliance:

yes (incl. certificate)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Purity: 97.3% (considered as 100%)Batch number: 9236-23

Radiolabelling:

no

Study design

Analytical monitoring:

yes

Details on sampling:

Samples were taken at different time intervals (0, 17, 21, 27, 41, 65, 89, 113 and 120 h) and stored at 4°C until assay by high performance liquid chromatography (HPLC). At pH 4 degradation was observed to occur before time point 17 hours; therefore, a second test was performed with two additional time points 2.4 and 3.5 hours.

Buffers:

- pH: pH 4, 7 and 9 buffers were used- Type and final molarity of buffer: Not specified- Composition of buffer: Not specified

Estimation method (if used):

N/A

Details on test conditions:

TEST SYSTEM- Type, material and volume of test flasks, other equipment used: The test was performed in 25 mL volumetric flasks.- Sterilisation method: Not specified- Lighting: The samples were placed in the dark at 50 °C.- Measures taken to avoid photolytic effects: The samples were placed in the dark.- Measures to exclude oxygen: Not specified- Details on test procedure for unstable compounds: N/A- Details of traps for volatile: N/A- If no traps were used, is the test system closed/open: Not specified- Is there any indication of the test material adsorbing to the walls of the test apparatus?: Not specified

TEST MEDIUM- Volume used/treatment: Not specified- Kind and purity of water: Not specified- Preparation of test medium: Not specified- Renewal of test solution: Not specified- Identity and concentration of co-solvent: The stock solution of the test article was prepared in acetonitrile.

OTHER TEST CONDITIONS- Adjustment of pH: Not specified- Dissolved oxygen: Not specified

Duration of test

Duration:

120 d

Temp.:

50 °C

Initial conc. measured:

50 other: mg/L in acetonitrile (concentration of stock solution)

Number of replicates:

For each pH, two samples of 12.5 µL each were prepared in a volumetric flask and the volume made up with the appropriate buffer.

Applicant's summary and conclusion

At each pH 4, the half life was equal to 1.78 hours.At pH 7 and 9, less than 10% hydrolysis is observed after 5 days.

Executive summary:

The hydrolysis study was performed in accordance with OECD Guideline 111 and EEC Directive 84/449 Method C.7.

At each pH 4, the half life was equal to 1.78 hours. At pH 7 and 9, less than 10% hydrolysis is observed after 5 days.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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